Project Management Clinical Trials

CATALINA ARREOLA

Telephone: 415-***-****

Email: *****************@*****.***

PROFILE

Committed researcher with a Master's education in the biomedical sciences discipline with a wealth of multidisciplinary research experience seeking to enhance knowledge gained from degree to improve the team. Recognized for having over six years of experience successfully overseeing and managing clinical data for up to 19 clinical trials including global Ph1b, Ph 1 and Ph2 studies. Results driven scientists with over 8 years of experience working to develop in vitro diagnostics products and Class 2 medical devices for ICON, Pzifer and Johnson and Johnson. Extensive experience designing and managing experiments to identify biomarkers like cytokines using patient samples. Experience managing biosamples including: cell lines, tissue biopsies, purified DNA, blood, and mammalian models. Experienced in training new staff, and mentoring incoming students. Ensured that regulatory compliance and data quality standards exceeded expectations. Demonstrable skills in project management and clinical trial operations to provide data for new and effective therapeutic treatments. TRANSFERABLE EXPERTISE

Research: Conduct thorough research, creating new ideas, perspectives and arguments. Possesses the ability to scrutinize research design for quality and feasibility with excellent analytical skills in both a qualitative and quantitative context.

Project Management: Check feasibility, teams and resources; set goals, defining roles and producing schedules of tasks. Multi Tasks and prioritizes flexibly to fulfill all assigned tasks within time constraints. Skilled at working under pressure and confidently meets targets.

Organization: An astute organizer, able to plan workload and prioritize tasks where necessary. Remains calm under pressure, ensuring tasks are completed to deadlines and standards. Communication and Interpersonal Skills: Offers exceptional communication skills and is confident in working with peers and management. Skilled in explaining technical information in an easy to understand form, verbally and in writing.

Team Working and Leadership: Effectively able to work as part of a team as well as on own initiative. Acknowledged throughout studies for leading and supporting peers during various projects and assignments. Takes on leadership positions in all fields.

Languages: Fluent in English and Spanish

KEY SKILLS

● Clinical trial coordination

● Biosamples and Biomarker

Analyst

● Study Biomarker Strategy

● Clinical Project Management

● Budgeting

● Scientific Presentation

● Data Coordination

● Cancer Biology

● Mentorship

● Research Protocols

● Translational Research

● Leadership

● Program Development

● Bioengineering

EMPLOYMENT HISTORY

Jun 2024 - Oct 2024 Clinical Research Coordinator, University of California, San Francisco

● Partnered on clinical research protocol development, execution and quality management as a key contributor on the team

● Developed educational materials in English and Spanish to be used within UCSF and widely in California regarding the hazards of silica

● Submitted protocols, informed consent forms, amendments, and other study-related documents to local and central IRBs

● Reported study progress to investigators

● Performed data entry of clinical data collected as part of a disease registry maintained at UCSF and administered exposure questionnaires

● Developed educational materials and a website regarding the hazards of engineered stone dust and silica dust May 2023 - July 2023 Research Assistant, https://careaccess.com/

● Performed a variety of administrative tasks in support of clinical trials and assisted in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies

● Coordinated and attended pre-study site visits, site initiation visits, and monitored visits with clinical staff and Sponsor/CRO representatives

● Maintained adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Mar 2023 - May 2023 Ally Navigator, Trial Library

● Served as the liaison between departments and services while overseeing data management and specimen collection

● Developed Standard Operating Procedures for the team

● Managed and coordinate study progress of various industry-sponsored clinical trials assessing the efficacy and safety of cancer immunotherapies

● Submit protocols, informed consent forms, amendments, and other study-related documents to local and central IRBs

Jun 2021 - July 2022 Clinical Research Data Coordinator, University of California San Francisco

● Served as the liaison between departments and services while overseeing data management and specimen collection

● Managed and coordinate study progress of various industry-sponsored clinical trials assessing the efficacy and safety of cancer immunotherapies

● Gathered and managed data for medical device studies and reported on study progress to the team

● Learned to analyze research data from medical devices

● Submit protocols, informed consent forms, amendments, and other study-related documents to local and central IRBs

● Reported study progress to investigators

● Supported the development of a clinical trial decision tool which aims to improve clinical trial awareness and identification

Aug 2016 - Jun 2021 Clinical Project Manager/Scientist - University of California, San Diego

● Worked under Dr. Christina Jamieson, tasked with supporting the delivery of numerous engineering projects to gain insights into the mechanisms underlying bone metastatic prostate cancer (BMPC)

● Demonstrated strong attention to detail to accurately collect and manage patient and laboratory data for pre-clinical research projects

● Delivered high quality, low cost results

● Promoted compliance by working to all set regulations, laboratory safety policy, and quality control policies; accurately recorded all quality control activities, conducted instrument and procedural calibrations and all required maintenance

● Undertook analysis to highlight problems and issues that were recognised to affect test performance or reporting of test results

● Gathered and analyzed research data for a preclinical

● Utilized a variety of biological techniques to characterize 3D patient and PDX derived organoid models

● Prepared manuscripts for publications on new xenograft models Oct 2019 - Jan 2021 Health Educator - Huckleberry Youth Programs

● Established partnerships with schools in San Francisco with the aim of improving health literacy among youth; facilitated medically accurate, youth centered workshops on several sexual and reproductive health topics to over 5,000 young adults

● Supported the San Francisco Unified School District with curriculum design for sexual and reproductive health education workshops

● Cooperated in the development of a Peer Health Education Summer Program, designed and delivered bespoke training sessions on a wide range of health topics most relevant to participants

● Provided reproductive health counseling to youth ages 12-24 Jun 2016 - Jun 2017 Resident Assistant - The Village at UCSD

● Served as first point of contact for residents, regulatory agencies, and sponsors, followed up to ensure resolution

● Utilized sound judgment skills to verify and determine eligibility of and gather consent from residents for student events, ensured compliance to all school policies

● Played a key role in monitoring visits, whilst undertaking regulatory audits of apartments and work, ensured policies of UCSD residential life and the UCSD Code of Conduct by embedding disciplinary action Voluntary and Leadership Experience:

Nov 2016 - Mar 2019 Volunteer Translator - UCSD Student Run Free Clinic Jul 2019 Volunteer - Flying Samaritans UCSD Volunteer Nov 2015 Volunteer - Border Health Project Clinic

Sep 2015 - Jun 2016 Board Member - HOPE

Sep 2016 - Aug 2017 Financial Officer - Society for Advancement of Chicanos and Native Americans in Science

Oct 2014 - Sep 2015 Health Educator - Women’s Community Clinic Jun 2012 - Aug 2014 Intern - HealthFirst Community Clinic Oct 2015 - Jun 2016 Research Volunteer - Sadler Lab, Department of Surgery, University of California, San Diego Moores Cancer Center

QUALIFICATIONS

May 2025 Master’s of Science, Biomedical Sciences - Touro University of California (TU) Jun 2018 Bachelor of Science, Public Health Minor General Biology - University of California, San Diego (UCSD)

Jun 2015 Associate in Arts (AA) Associate in Science (AS) - Community College of San Francisco PUBLICATIONS

● Muldong, M., Burner, D., Wu, CN, Mendoza, T., Arreola, C., Lee, S., Jamieson, CHM, Cacalano, NA, Kulidjian, AA, Kane, CJ, Jamieson, CAM. Enzalutamide Treatment Results in Anti-Androgen Resistance in Patient Derived Bone Metastatic Prostate Cancer Models. Society for Basic Urologic Research (SBUR) Annual Fall Symposium, Nov 8-11, 2018, Palm Springs, CA. AJCEU 2018

● Burner, DN, Mendoza, TR, Muldong, MT, Lee, S., Arreola, C., Miakicheva-Greenburg, O, Zhu, W, Wu, CN, Jamieson, CHM, Cacalano, NA, Kulidjian, AA, Kane, CJ, Jamieson, CAM. Mechanisms of anti-androgen resistance in a 3D patient derived organoid (PDO) model of bone metastatic prostate cancer. Society for Basic Urologic Research (SBUR) Annual Fall Symposium, Nov 8-11, 2018, Palm Springs, CA. AJCEU 2018

● Lee, S.*, Arreola, C., Burner, D., Muldong, M., Mendoza, T., Wu, CN, Jamieson, CHM, Cacalano, NA, Kulidjian, AA, Kane, CJ, Jamieson, CAM. Prostate cancer bone metastasis patient-derived three-dimensional organoids undergo a budding-like cell extrusion process to form cyst/gland-like structures: an in vitro model of metastatic tumor formation. Society for Basic Urologic Research (SBUR) Annual Fall Symposium, Nov 8-11, 2018 Palm Springs, CA. AJCEU 2018. *Winner of Travel Award SBUR 2918 Fall Symposium

● Burner, DN, Mendoza, TR, Muldong, MT, Lee, S., Arreola, C., Miakicheva-Greenburg, O, Zhu, W, Wu, CN, Jamieson, CHM, Cacalano, NA, Kulidjian, AA, Kane, CJ, Jamieson, CAM. Mechanisms of anti-androgen resistance in a 3D patient derived organoid (PDO) model of bone metastatic prostate cancer. Moderated Poster MP81, American Urologic Association (AUA) Annual Conference 2019, May 3-6, 2-19, Chicago, IL

● Muldong, M., Burner, D., Wu, CN, Mendoza, T., Arreola, C., Lee, S., Jamieson, CHM, Cacalano, NA, Kulidjian, AA, Kane, CJ, Jamieson, CAM. Enzalutamide Treatment Results in Anti-Androgen Resistance in Patient Derived Bone Metastatic Prostate Cancer Models, Moderated Poster MP68, American Urologic Association (AUA) Annual Conference 2019, May 3-6, 2-19, Chicago, IL

● Jamieson, CAM, Lee, S., Burner, DN, Mendoza, TR, Muldong, MT, Zuniga, A, Arreola, C, Wu, CN, McDermott, JJ, Narasimhan, RS, Kang, SK, Jamieson, CHM, Cacalano, NA, Kim, IY, Willert, K, Gaasterland, T, Kulidjian, AA, Mckay, RR, Kane, CJ,. Targeting the WNT5A Receptor, ROR1, in Prostate Cancer. “,” Speaker and Poster, Prostate Cancer Foundation (PCF) 26th Annual Scientific Retreat, October 24-27th, 2019, Carlsbad, CA

● Lee, S., Burner, DN, Mendoza, TR, Muldong, MT, Zuniga, A, Arreola, C, Wu, CN, McDermott, JJ, Narasimhan, RS, Kang, SK, Jamieson, CHM, Cacalano, NA, Kim, IY, Willert, K, Gaasterland, T, Kulidjian, AA, Mckay, RR, Kane, CJ,. Jamieson, CAM. Targeting the WNT5A Receptor, ROR1, in Prostate Cancer. “Novel Discoveries in Urology: Big Data to Microbiome,” November 7 -10, 2019, Society for Basic Urologic Research (SBUR) Nov 2019, New Orleans, LA

● Jamieson, CAM, Muldong, MT, Lee, S, Wu, CN, Burner, DN, Mendoza, TR, Arreola,C, Zuniga, A, Cacalano, NA, Jamieson, CH, Kane, CJ, Kulidjian, AA. Enzalutamide treatment of patient derived bone metastatic prostate cancer xenograft models implanted in the bone resulted in durable progression to castration resistant prostate cancer (CRPC). American Association for Cancer Research (AACR) Annual Conference 5/27/20-5/29/20: Virtual Poster #6109 presentation, May 28th, 2020

● Jamieson, CAM, Lee, S, Mendoza, TR, Burner, DN, Muldong, MT, Wu, CN, Arreola, C, Zuniga, A, Miakicheva-Greenburg, O, Zhu, W, Cacalano, NA, Jamieson, CH, Kane, CJ, Kulidjian, AA, Gaasterland, T. Emergence of novel basal-luminal hybrid cells and loss of SARS-CoV-2 factors, TMPRSS2 and ACE2, in prostate cancer organoids under androgen deprivation treatment. Society for Urological Research (SBUR) Annual Meeting, Nov11-14, 2020 Virtual

PRESENTATIONS / ABSTRACTS

● Christina A.M Jamieson, PhD, Sanghee Lee, PhD, Danielle N. Burner, BS, Theresa R. Mendoza, MS, Michelle T. Muldong, BS, Abril Zuniga, BS, Catalina Arreola, BS, Christina N. Wu, PhD, John McDermott, BS, Rekha Narasimhan, BS, Sungu-Kang, Issac Kim, MD, Karl Willert, PhD, Terry Gaasterland, PhD, Anna Kulidjian, MD, Rana McKay, MD, Christopher Kane, MD. Targeting the WNT5A Receptor, ROR1, in Prostate Cancer. Presented at the Prostate Cancer Foundation Retreat. (October 2019)

● Christina Jamieson, PhD, Michelle T. Muldong, BS, Danielle N. Burner, BS, Theresa R. Mendoza, MS, Sanghee Lee, PhD, Catalina Arreola, BS, Tris Mendoza, BS, Nicholas Cacalano, PhD, Catriona Jamieson, PhD, Terry Gaasterland, PhD, Christopher Kane, MD, Anna Kulidjian, MD, Christina Jamieson, PhD. Mechanisms of Anti-Androgen Resistance in a 3D Patient Derived Organoid Model of Bone Metastatic Prostate Cancer. The Journal of Urology. (April 2019)

● Michelle T. Muldong, BS, Danielle N. Burner, BS, Christina N. Wu, PhD, Theresa R. Mendoza, Catalina Arreola, BS, Sanghee Lee, PhD, Catriona Jamieson, MD, Nicholas A. Cacalano, PhD, Anna A Kulidjian, PhD, Christopher J. Kane, MD, Christina Jamieson, PhD. Enzalutamide Treatment Results in Anti-Androgen Resistance in PatientDerived Bone Metastatic Prostate Cancer Models. The Journal of Urology (October 2018)

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